Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406003

Enrollment

Registered

2006-12-04

Start date

2006-03-24

Completion date

2006-04-26

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

BRL029060/Paroxetine CR, pharmacokinetics, safety

Brief summary

The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile

Interventions

DRUGParoxetine controlled release tablet

Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 19-45 years healthy Chinese * Body weight \> 50 kg * BMI between 19-25 * serological negative for HIV, syphilis and hepatitis B and C * no abnormalities in ECG * Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Exclusion criteria

* History of chronic physical/mental disease, current disease and concomitant medication

Design outcomes

Primary

Measure	Time frame
To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects	Up to 32 days

Secondary

Measure	Time frame
To describe Safety profile of healthy subjects when dosed with paroxetine controlled release	Up to 32 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026